TestGene develops and manufactures kits for molecular genetics. Products are intended for use in research, practical medicine, and in the fields of molecular biology. The focus area – non-invasive genetic testing in obstetrics and oncology. The company has its own production laboratory with the necessary equipment for manufacturing and quality assurance of kits based on "real time PCR". The company team of internationally recognized researchers constantly improves the products according to the latest scientific achievements.

1. Noninvasive prenatal testing of fetal gender and
RHD status at early pregnancy.
Andrey Toropovsky
PhD, CEO
“TestGene” LLC

2. “TestGene” LLC
• Established at 2012 in Dimitrovgrad, Russia
• 11 team members, 3 with PhDs
• Own laboratory placed in ULNANOTECH
• Partner’s laboratory premises in Moscow
• Trade area covers Russia and CIS states
• More than 100 genetic products launched
• New products are constantly developing
Team’s Achievements
Start-1 FASIE
Start-2 FASIE
Prize-Winner in innovative competitions
in Russia, Korea and Taiwan.
Prize-Winner of Business Success-2014.

3. The diagnostic complex
• “Test-RHD" – test-system for noninvasive detection of fetal RND gene
since 10th week of pregnancy;
• “Test-SRY" – test-system for noninvasive detection of fetal SRY gene
since 7th week of pregnancy;
• Reagents kits for DNA isolation from biomaterials.

4. Relevance of the noninvasive prenatal
fetal RHD-status testing since 10th week
of pregnancy (Test-RHD):
● 15% of pregnant women are RHD-negative
and there is a possibility of RHD conflict in
50% of cases. RHD conflict leads to Hemolytic
disease of newborn (HDN).
● HDN is the major cause of newborn or fetal
death in utero.

5. «Test-RHD» & «Test-SRY» - safe
fetus DNA diagnostic
Pregnant women submits
7 ml of dark-red blood

6. The testing process consists of
3 simply steps

7. Rh-negative pregnant women
Rh-negative
fetus
Labor and delivery as in
case of normal
pregnancy
Rh-positive
fetus
High-risk of Rh-
sensitization and
HDFN

8. Rh-sensitization risk:
Labor and delivery
The presence of antibody titre monitoring each
month during the whole pregnancy
If antibody titres are absence- injection of
immunoglobulin at 28 gestation week and within 72
hours after delivery
in the case of Rh-sensitization - Ultrasound
investigation every 4 weeks starting from 20th week
of pregnancy, every 14 days since 32nd week
Solution to the question about delivery date and
delivery approach

9. Test-RHD: the results of
TestGene’s research*
*12 independent clinics within Russia and
CIS states
Incident count 811
Fetal RHD gene is detected 652
Fetal RHD gene is not detected 159
False-positive results 7 (1,07%)
False-negative results 0

10. Test-SRY: the results of
TestGene’s research*
*12 independent clinics within Russia and CIS
states
Incident count 1003
Fetal SRY gene is detected 407
Fetal SRY gene is not detected 596
False-positive results 1 (0,49%)
False-negative results 4 (0,67%)

11. Social and clinical benefits
”Innovations should be available”
• “Test-RHD” allows to take timely measures to prevent
newborn death
• “Test-SRY” has particular importance for families at the sex-
linked disease risk
• “DNA-plasma”: qualitative DNA isolation – key for accurate
diagnostic result
• TestGene LLC conducts development of novel products which
are available for all population stratums
• TestGene LLC headhunts gifted and promising specialists

12. TestGene’s projects
• test system for non-invasive prenatal testing of Down syndrome and other
common aneuploidies since 9 week of pregnancy
Down's syndrome (21XXX), Patau (13XXX), Edwards (13XXX),
Turner (X0) and Klinefelter (XXY)
• Noninvasive and alternative cancer early detection
Prostate cancer
Breast cancer
• Kits for nucleic acid extraction
Based on using magnetic sorbents
Based on using spin columns
Based on Rapid one-step selection

13. Thank you for
attention!
We are open for cooperation
id@testgen.ru
director@testgen.ru